The government, on Thursday, issued regulatory pathway related to Covid-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). The Central Drugs Standards Control Organisation (CDSCO), headed by Drugs Controller General of India or DCGI, has laid out the pathway according to which the former will prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders. Applicants for grant of approval for restricted use in emergency situation may be submitted to CDSCO. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India in case it does not have an Indian subsidiary.
CDSCO will process such applications for restricted use in emergency situation and DCGI will consider and take a decision within three working days from date of submission of complete application by the applicant. DCGI will issue permission for restricted use in emergency situation with the conditions that vaccine shall be used according to the guidelines prescribed under national Covid-19 vaccination programme. First 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further vaccination program. Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.
Applications for restricted use in emergency situation for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and application for import license. CDSCO will process applications for registration certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and Import License, within three working days from the date of approval of Restricted Use in Emergency Situation.
According to the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory(CDL), Kasauli before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme.
“The applicant will use Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO. CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorize the applicant to use the vaccine,” the release said.
CDSCO will approve the protocol for the bridging trial in consultation with subject expert committee within 7 days of the receipt of the proposal. Applicant will conduct the bridging trial within the time lines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO. After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in emergency situation.